Knot tying and suturing as a method to approximate tissue is a critical element of surgery. Skill in knot tying is so basic to surgery that medical students learn knot tying early in their studies, and they routinely practice tying various kinds of knots with one hand or both hands.
In laparoscopic procedures, the tying of sutures and other knots is especially difficult and it is not uncommon for the tying of a single knot to require an hour or more. In laparoscopy, there is no tactile sense to the surgeon because of the surgeon's lack of direct contact with the tissue, since the surgeon's sense of feel is reduced by the imposition of the laparoscopic instruments. Further, the surgeon is unable to view directly the site of the surgery, but instead must rely upon a two-dimensional video screen which both magnifies the site and eliminates the opportunity for any depth perception.
Another difficulty is presented by the fact that laparoscopic surgery necessarily is conducted in a confined space, and the instruments are preferably positioned in this confined space in a particular orientation in relation to one another and in relation to the patient. For example, it is desirable that within this confined space, the instruments not be too close together or too far apart, that they be visible through the laparoscope, and that they enter the field of view of the laparoscope tangentially rather than coaxially so that they do not obstruct the view too much. It is also desirable that the instruments advance out of their sheaths toward the video screen and away from the laparoscope in order to avoid the surgeon having to operate under "mirror vision". Finally, procedures employing a single operating port encourage the surgeon to use the dominant hand to manipulate the instrument in the port while using the other hand merely to stabilize the laparoscopic sheath. However, knot tying typically requires both hands, and so an assistant or a device is then necessary to stabilize the sheath while both the surgeon's hands tie the knot.
Suturing and other knot tying are applicable to many different laparoscopic procedures. In laparoscopic cholecystectomy, the cystic duct or artery can be ligated using manual suturing or knot tying techniques rather than an automatic clip. In a laparoscopic appendectomy, the surgeon can use slip knots rather than using a disposable linear stapler. Although laparoscopic staplers have been developed, laparoscopic sutures and other knots will still be needed for many purposes such as closing defects in a staple line, placing purse-string sutures for end-to-end stapling, closing mesenteric defects, and ligating large blood vessels.
Knots used in laparoscopy may be tied either intracorporeally or extracorporeally. Internal knotting requires a high level of expertise by the surgeon, and normally requires at least two operating cannulae and associated graspers. For a square knot, a loop is made in a first end of the material using the first grasper; the second grasper is inserted through the loop and used to grasp the second end; the second end is pulled through the loop to produce a flat knot; another loop is made in the first end of the material using the first grasper; the second grasper is inserted through that loop and used to grasp the second end; and the second end is pulled through that loop to produce an opposing flat knot. The resulting square knot can then be tightened with the two graspers. The first throw may be a simple overhead knot or may be a surgeon's knot. Additional throws may be applied over the second throw to provide additional security. It is important that sequential throws are in opposite directions to avoid producing a "granny" knot.
Many other types of knots are possible depending on the characteristics of the material used, the dexterity of the surgeon, and the circumstances at the suture site. Many knots in laparoscopy are slip knots of some kind to allow the knot to be cinched against the sutured material. These include the Roeder knot, a clinch knot and so-called "hangman's" knots.
Extracorporeally tied knots are obviously much easier to tie than intracorporeally tied knots, but extracorporeally tied knots can be very difficult to place effectively. A number of devices have been developed to assist in placing an extracorporeally tied knot including the "Clarke" ligator, the "Weston" ligator (see "A New Cinch Knot", Obstetrics & Gynecology, Vol. 78, No. 1, July 1991, 144-47) and other devices. See, e.g. "An Improved Needleholder for Endoscopic Knot Tying", Fertility and Sterility, Vol. 58, No. 3, Sept. 1992, 640-42; "Roeder Knot for Tight Corners in Conventional Abdominal Surgery", J. R. Coll. Surg. Vol. 36, Dec. 1991, 412; "A Simple Method for Ligating with Straight and Curved Needles in Operative Laparoscopy", Obstetrics and Gynecology, Vol. 79, No. 1, Jun. 1992, 143-47. Most of the devices for placing an extracorporeally tied knot fall into the category of "knot pushers". A knot is formed extracorporeally and is pushed through the cannula by sliding it down the material using a device that engages the knot. The Clarke ligator mentioned above was one of the first knot pushers. It simply consists of a grasping end and an end opposite the grasping end with an open ring. It engages the knot by passing the material through the opening in the ring.
There are also a number of patented knot pushers, including those described in U.S. Pat. Nos. 5,234,445 by Walker, 5,234,444 by Christondias, 5,217,471 by Burkhart, 5,192,287 by Fournier, 5,163,946 by Li, 5,129,912 by Noda, 5,133,723 by Li, 5,084,058 by Li, 3,871,379 by Clarke, and 2,012,776 by Roeder. There are also a number of patents directed more toward endoscopic knotters, including U.S. Pat. Nos. 5,234,443 by Phan, 5,211,650 by Noda, 4,961,741 by Hayhurst, 4,923,461 by Caspari, 4,890,614 by Caspari, 4,641,652 by Hatterer, and 4,602,635 by Mulhollan. It is believed that an important limitation to these devices is that they do not include a disposable knot carrier in the manner of the present invention.